OECD Template #8: Water solubility (Version 2-June
2012)

The following table gives a
detailed description of the type of information prompted for by the data entry
fields. Elements provided to guide the user include predefined picklist phrases, freetext templates
and context-sensitive help texts. In addition, technical elements are provided,
i.e. field and data types, explanations for use in Data Element Dictionary
(DED) and the xml schema. The conventions used are explained in part 'Introduction
and Format of OECD Harmonised Templates'.

Field number

Field description

[Field label]

Field type

Data type

Group ID

Max occ.

Detail level

Picklist code

Remarks, Picklist, Freetext
template

Help text

Explanation for use in Data Element Dictionary (DED)

XML Schema

ADMINISTRATIVE
DATA

REMARKS:

Under
this main heading, fields are subsumed for identifying the purpose of the
record (e.g., 'key study'), the type of result
(e.g., 'experimental study'), data waiving indication (if any), reliability
indication, and flags for indicating the regulatory purpose envisaged and/or
any confidentiality restrictions. This kind of data characterise
the relevance of a study summary and may therefore be displayed on top of
each template. For detailed guidance, refer to Administrative data.

SE04.08.00.0215

DATA SOURCE

[Data
source]

HEAD-1

Heading level 1

[N/A]

1

1

[N/A]

Main heading under which generic 'Data source' fields are subsumed.

SE04.08.00.0219

Reference

[Reference]

HEAD BLOCK

Block label

g146

10

1

[N/A]

Indicate the bibliographic reference of the study report or publication
the study summary is based on. Always enter the primary reference in the
first block of fields (i.e. Sort no. = 1), if there are
more than one reference to be cited. Copy this block of fields for specifying
any other references related to this record (e.g. report of a preliminary
study or other documentation). If results of a study report have been
published, indicate the full citation of that publication(s) in addition to
the reference of the original study.

Indicate the type of reference, e.g. 'Study report' or 'Publication'.
Select 'Other company data' to characterise any
unpublished information from a company other than a study report. Select
'Grey literature' for any other unpublished information or 'other:' and
specify.

For ease of sorting and searchability use following
convention: Surname, Initial (Example 1: White D, Ruehl
KJ, Borman SA & Little J. Example 2: Hartley M
& Murray W (avoid unnecessary full-stops, commas)). If no individuals are
cited as authors, enter name of company or organisation
or 'Anon.' as appropriate.

Note that the complete bibliographic reference may appear in this field
after migration of unstructured data from existing databases.

Name(s) of author(s) of the study report or publication.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_AUTHOR>

<i5:REFERENCE_AUTHOR>

SE04.08.00.0240

Year

[Year]

YEAR

NUMBER/4/###0

g146

1

1

[N/A]

Enter year of study report or publication. For a study report this field should
be completed to include it in any searches, regardless of whether the
complete date is given in field 'Report date'.

Year of the study report or publication.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_YEAR>

<i5:REFERENCE_YEAR>

SE04.08.00.0250

Title

[Title]

TEXT

STRING/255

g146

1

1

[N/A]

Include the title of the report. For publications, include the title of
the article of a journal or article/chapter of a book (e.g. handbook).

Title of a study report or title of published article of journal or book
(e.g. handbook).

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TITLE>

<i5:REFERENCE_TITLE>

SE04.08.00.0260

Bibliographic source

[Bibliographic
source]

TEXT

STRING/255

g146

1

1

[N/A]

Not relevant for any study report. For publications or any other
literature source (grey literature) specify the following type of information:
(i) Title of scientific journal or book (e.g. if handbook); (ii) Volume of
journal; (iii) Editor, publisher, place of publication for books or articles
in books; (iv) Pagination.

Select appropriate indication for data access. Enter 'Not applicable' if the
summary consists of information that is commonly accessible such as guidance
on safe use.

Indication for data access.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE04.08.00.0321

Data access

[no
label]

OTHERTEXT

STRING/255

[N/A]

1

1

[N/A]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE04.08.00.0330

Data protection claimed

[Data
protection claimed]

LIST-CLOSED-SUP

STRING/255

[N/A]

1

1

Z30

Picklist Values:

yes
|| yes, but willing to share || yes, but not willing to share

Indicate as appropriate. Note: 'yes' should be selected only if 'Data submitter
is data owner' or 'Data submitter has Letter of Access'. Options 'yes, but
willing to share' or 'yes, but not willing to share' may be relevant for
specific regulatory programmes where the submitter
is requested to indicate whether he is willing to share studies (e.g. with
vertebrates).

In the supplementary remarks field, include an explanation as appropriate,
i.e. justification for denial of sharing the corresponding study or refer to
a document attached that provides justification (e.g. 'for justification see
attached document X')

Indication if data protection is claimed by the submitter who has to be
data owner or have letter of access.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE04.08.00.0331

Data protection claimed

[no
label]

SUP-TEXT

STRING/255

[N/A]

1

1

[N/A]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE04.08.00.0340

Cross-reference to same study

[Cross-reference
to same study]

TEXTAREA

STRING/2000

[N/A]

1

1

[N/A]

A cross-reference can be included to indicate that the same study is recorded
in another record. Indicate the respective chapter and record ID and enter
relevant explanatory text. This may be useful if specific endpoints of a
given study are described in another chapter (e.g. results on reproduction
toxicity in case of a combined repeated dose / reproduction toxicity study)
or if more than one experiment is described by the same study report, but
included in separate records.

Check with the relevant guidance document whether all the methodology details
must be repeated or whether a cross-reference to the same study in another
chapter may suffice.

Note that any such cross-reference may become useless if a record is
either printed or exchanged on its own.

Indication that the same study is described in another study summary /
chapter of the data set.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:CROSSREF_SAMESTUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE04.08.00.0345

MATERIALS AND METHODS

[Materials
and methods]

HEAD-1

Heading level 1

[N/A]

1

1

[N/A]

Main heading under which generic 'Materials and methods' fields are subsumed.

SE04.08.00.0349

Test guideline

[Test
guideline]

HEAD BLOCK

Block label

g147

5

1

[N/A]

Indicate according to which test guideline the study was conducted. If no
test guideline was explicitly followed, but the methodology used is
equivalent or similar to a specific guideline, you can indicate so in the
'Qualifier' subfield preceding the field 'Guideline'.

Copy this block of fields for specifying more than one guideline (e.g. US
EPA in addition to OECD guideline).

Heading of field block 'Guideline'

SE04.08.00.0350

Qualifier

[Qualifier]

LIST-CLOSED

STRING/255

g147

1

1

Z06

Picklist Values:

according
to || equivalent or similar to || no guideline followed || no guideline
available || no guideline required

Select appropriate qualifier, i.e.

- 'according to' (if a given test guideline was followed);

- 'equivalent or similar to' (if no test guideline was explicitly
followed, but the methodology is equivalent or similar to a specific
guideline);

- 'no guideline followed' (if none of above qualifiers apply. If so, fill
in field 'Principles of method if other than guideline');

- 'no guideline available' (if so, fill in field 'Principles of method if
other than guideline').

- 'no guideline required' (if so, fill in field 'Principles of method if
other than guideline').

An indicator signifying how strict the guideline given in the subsequent
field 'Guideline' was followed or whether no guideline was used or
available/required.

Select the applicable test guideline, e.g. 'OECD Guideline xxx'. If the
test guideline used is not listed, choose 'other guideline:' and specify the
test guideline in the related text field.

In this text field, you can also enter any remarks as applicable,
particularly:

- To include any other title of the test guideline draft used, a subtitle,
another version or update number and the year of update (For instance, different
titles and/or numbers may exist for a given EU test guideline.);

- To indicate if a the study was performed prior to the adoption of the
test guideline specified;

- To indicate if the methodology used was based on an extension of the
test guideline specified.

The name of the guideline followed in performing the study or to which the
method used can be compared. Also indication if no guideline was used, availaible or required. In supplementary remarks field
indication of guideline version or title if deviating from the picklist value., or of additional test guidelines cited.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE>

SE04.08.00.0361

Guideline

[no
label]

SUP-TEXT

STRING/255

g147

1

1

[N/A]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE_TXT>

SE04.08.00.0370

Deviations from guideline

[Deviations]

LIST-CLOSED-SUP

STRING/255

g147

1

1

Z08

Picklist Values:

yes
|| no || no data || not applicable

For robust study summaries or as requested by the regulatory programme,
indicate if there are any deviations from the test guideline specified. If
'yes' is selected, only briefly state relevant deviations in the
supplementary remarks field (e.g. 'other species used'); details should be
described in the respective fields of the section MATERIALS AND METHODS.

Indication that a study contains deviations from the standard test
protocol.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION>

SE04.08.00.0371

Deviations from guideline

[no
label]

SUP-TEXT

STRING/255

g147

1

1

[N/A]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION_TXT>

SE04.08.00.0380

Type of method

[Type
of method]

LIST-OPEN-SUP

STRING/255

[N/A]

1

1

P37

Picklist Values:

column
elution method || flask method || analysis || ICP-MS || other:

Indicate which type of method was used according to the options provided
in the test guideline or, if no guideline was applied, according to the
methodology used.

Indication of type of method used according to test guideline.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:METHOD_TYPE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE04.08.00.0381

Type of method

[no
label]

SUP-TEXT

STRING/255

[N/A]

1

1

[N/A]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:METHOD_TYPE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE04.08.00.0390

Principles of method if other than guideline

[Principles
of method if other than guideline]

TEXTAREA

STRING/32768

[N/A]

1

1

[N/A]

If no guideline was followed, include a description of the principles of
the test protocol or estimated method used in the study. Details should be
entered in appropriate distinct fields of section MATERIALS AND METHODS if
available. Also provide a justification for using this method if appropriate.

If an estimation method was used (to be indicated in field 'Study result
type') state the equation(s) and/or computer software or other methods
applied to calculate the value(s).

Description of the test protocol or estimated method used in the study, if
other than a guideline, and justification for using this method if
appropriate.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:METHOD_NOGUIDELINE>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE04.08.00.0400

GLP compliance

[GLP
compliance]

LIST-CLOSED-SUP

STRING/255

[N/A]

1

1

Z40

Picklist Values:

yes
(incl. certificate) || yes || no || no data

Indicate whether the study was conducted following Good Laboratory
Practice or not. Select 'yes (incl. certificate)' if a GLP certificate of a
test facility is available. Select 'yes' if a GLP compliance statement is
available, but no information on a GLP certificate. You can give an
explanation in the supplementary remarks field, e.g. for explaining why GLP
was not complied with or for specifying which (national) GLP was followed.

Indication whether a GLP certificate or compliance statement is available.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE04.08.00.0401

GLP compliance

[no
label]

SUP-TEXT

STRING/255

[N/A]

1

1

[N/A]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE04.08.00.0405

Test materials

[Test
materials]

HEAD-2

Heading level 2

[N/A]

1

1

[N/A]

Subheading of section 'Test materials'

SE04.08.00.0410

Test material equivalent to submission substance identity

[Identity
of test material same as for substance defined in section 1 (if not
read-across)]

LIST-CLOSED

STRING/255

[N/A]

1

1

Z38

Picklist Values:

yes
|| no

Select 'yes' or 'no' from the drop-down list for indicating that the
identity of the test material is the same or is not the same, respectively,
as for substance defined in section 1 (General information). In addition, the
identity of the test material should be specified in the subsequent block of
fields 'Test material identity'.

NOTE: You cannot update this field, if a completed record is copied to
another submission substance as reference. Therefore, in case of read-across
the indication of 'yes' is not relevant.

Indicator showing whether the test material used is equivalent to the
submission substance identity.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:TESTMAT_INDICATOR>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE04.08.00.0419

Test material identity

[Test
material identity]

HEAD BLOCK

Block label

g148

10

1

[N/A]

Indicate the identity of the test material for one or more appropriate identifiers,
e.g. CAS number, CAS name, IUPAC name. Copy this block of fields as
appropriate.

NOTE: In order to avoid confusion on the test material identity it is
highly recommended to enter at least one substance identifier, regardless of
what has been enterd in field 'Identity of test
material same as for substance defined in section 1 (if not read-across)'.

Heading of field block 'Test material identity'

SE04.08.00.0420

Identifier

[Identifier]

LIST-OPEN

STRING/255

g148

1

1

Z39

Picklist Values:

CAS
name || CAS number || Common name || EC name || EC number || IUPAC name ||
TSCA name || other:

Select an appropriate identifier from drop-down list, e.g. 'CAS number'.
Use 'Other:' and specify, if identity according to a standard identifier is
not known or if an additional chemical name or number is provided.

Indicator specifying the type of chemical identifier, e.g. CAS name.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER>

SE04.08.00.0421

Identifier

[no
label]

OTHERTEXT

STRING/255

g148

1

1

[N/A]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER_TXT>

SE04.08.00.0430

Identity

[Identity]

TEXT

STRING/2000

g148

1

1

[N/A]

Select the corresponding substance identity from drop-down list or enter
manually if the identity is not available from the list or if no list is
provided for the type of identifier selected.

Identity of the chemical substance used in the study or referred to in the
record.

Select the test material form from the drop-down list. If the form of the
test chemical is not available in the list, select 'other:' and specify in
the adjacent field. If the test material form is unknown, select 'no data'.

Form of the substance, i.e. powder, crystalline, compact, viscous, etc.

Use freetext template and delete/add elements as
appropriate. Enter any details that could be relevant for evaluating this
study summary or that are requested by the respective regulatory programme.
Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or
EU REACH) thereof.

Note that any information that can be claimed confidential should be
included in the subsequent field 'Confidential details on test material'.

Explanations:

- Name of test material (as cited in study report): only if different from
any other identifiers provided in the preceding fields.

- Molecular formula (if other than submission substance): specify

- Molecular weight (if other than submission substance): specify

- Smiles notation (if other than submission substance): provide if
available

- InChl (if other than submission substance):
provide if available

- Structural formula attached as image file (if other than submission
substance): see Fig.: only if different from submission substance. Indicate
Fig. no. if a file is attached in field 'Attached document', e.g. state 'see
Fig. 1'.

Enter any confidential information on the test material in this separate
field. Use freetext template and delete/add
elements as appropriate. Enter any details that could be relevant for
evaluating this study summary or that are requested by the respective
regulatory programme. Consult the programme-specific guidance (e.g. OECD
HPVC, Pesticides NAFTA or EU REACH) thereof.

Explanations:

- Analytical purity: specify in %

- Impurities (identity and concentrations): specify

- Composition of the test material, percentage of components: specify if
applicable

- Purity test date: provide if available

- Lot/batch No.: : provide if available

- Expiration date of the lot/batch: : provide if available

- Isomers composition: specify if applicable

Confidential details on the actual test material.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:TESTMAT_CONFIDENTIAL_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE04.08.00.0460

Details on methods

[Details
on methods]

TEXTAREA

STRING/32768

[N/A]

1

2

[N/A]

Provide details on the methods including analytical method, method
validation data and all relevant chromatograms (attach as appropriate)
particularly if no guideline was used. If the test substance appears
'insoluble' in water, provide the detection limit of the analytical method.
Also provide the purity of water used.

If an estimation method was used (to be indicated in field 'Test result
type') state the equation(s) applied to calculate the water solubility.

Details on experimental or calculation/estimation methods used.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:METHOD_DETAILS>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE04.08.00.0470

Any other information on materials and methods incl. tables

[Any
other information on materials and methods incl. tables]

RICHTEXT

STRING/256000

[N/A]

1

1

[N/A]

In this field, you can enter any information on materials and methods, for
which no distinct field is available, or transfer free text from other
databases. You can also open a rich text editor and create formatted text and
tables or insert and edit any excerpt from a word processing or spreadsheet
document, provided it was converted to the HTML format.

Note: One rich text editor field each is provided for the MATERIALS AND
METHODS and RESULTS section. In addition the fields 'Overall remarks' and
'Executive summary' allow rich text entry.

Rich text editor field for creating formatted text and tables or inserting
and editing any excerpt from a word processing or spreadsheet document,
provided it was converted to the HTML format.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:REM_ME_TC>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE04.08.00.0475

RESULTS AND DISCUSSION

[Results
and discussions]

HEAD-1

Heading level 1

[N/A]

1

1

[N/A]

Main heading under which generic 'Results and discussion' fields are
subsumed.

SE04.08.00.0479

Water solubility

[Water
solubility]

HEAD BLOCK

Block label

g149

50

1

[N/A]

Enter mean water solubility or range if reported so and indicate the
temperature and pH conditions in the respective subfields. If necessary, copy
this block of fields for each temperature and pH conditions at which the
water solubility was determined.

If the pH value was measured with another test substance concentration
than the given water solubility concentration, specify the concentration with
unit in field 'Details on remarks'.

Heading of field block 'Water solubility'

SE04.08.00.0480

Water solubility

[Water
solubility]

LIST-CLOSED

STRING/255

g149

1

1

A02-1

Picklist Values:

>
|| >= || ca.

Enter a numeric value or a range of numeric values according to following
conventions:

(i) In the first numeric field, enter a single value (Qualifier subfield
left blank) or a value if preceded by '>', '>=' or 'ca.' (e.g. '20',
'ca. 20', '>20').

(ii) In the second numeric field, enter a single value if preceded by
'<' or '<='.

(iii) Use both numeric fields and, as required, the lower and upper
qualifier field to enter a range of numeric values (e.g. '2 - 8' or '>2
<8').

Water solubility: Lower qualifier field providing a list with following
operators: >, >=, and ca.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:WATERSOL>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOQUALIFIER>

SE04.08.00.0490

Water solubility

[no
label]

NUM

NUMBER/20/########0.#########

g149

1

1

[N/A]

Water solubility: Lower numeric field for entering a numeric value
preceded either by no operator, '>', '>=' or 'ca.' (e.g. '20',
'>20', '>=20', '20')

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:WATERSOL>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOVALUE>

SE04.08.00.0500

Water solubility

[no
label]

LIST-CLOSED

STRING/255

g149

1

1

A02-2

Picklist Values:

<
|| <= || ca.

Water solubility: Upper qualifier field providing a list with following
operators: <, <=, and ca.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:WATERSOL>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPQUALIFIER>

SE04.08.00.0510

Water solubility

[no
label]

NUM

NUMBER/20/########0.#########

g149

1

1

[N/A]

Water solubility: Upper numeric field for entering a numeric value only if
either a lower value is already entered to specify a numeric range or if the
numeric value is preceded by either operator '<' or '<='.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:WATERSOL>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPVALUE>

SE04.08.00.0520

Unit of water solubility

[Water
solubility]

LIST-OPEN

STRING/255

g149

1

1

P08

Picklist Values:

µg/L
|| mg/L || g/L || g/cm³ || kg/m³ || ppb || vol% ||
other:

Select from drop-down list.

Unit of water solubility.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:WATERSOL>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UNIT>

SE04.08.00.0521

Unit of water solubility

[no
label]

OTHERTEXT

STRING/255

g149

1

1

[N/A]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:WATERSOL>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UNIT_TXT>

SE04.08.00.0530

Temperature

[Temp.]

NUM

NUMBER/20/########0.#########

g149

1

1

[N/A]

Enter numeric value.

Temperature (preferably in °C) at which water solubility was determined.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:WATERSOL>

<i5:set>

<i5:VALUEUNIT_TEMP_VALUE>

<i5:TEMP_VALUE>

SE04.08.00.0540

Unit

[Water
solubility]

LIST-CLOSED

STRING/255

g149

1

1

A102

Picklist Values:

°C
|| K || °F

Select from drop-down list.

Unit of temperature.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:WATERSOL>

<i5:set>

<i5:VALUEUNIT_TEMP_VALUE>

<i5:TEMP_UNIT>

SE04.08.00.0550

pH value

[pH]

LIST-CLOSED

STRING/255

g149

1

1

A02-1

Picklist Values:

>
|| >= || ca.

Enter a numeric value or a range of numeric values according to following
conventions:

(i) In the first numeric field, enter a single value (Qualifier subfield
left blank) or a value if preceded by '>', '>=' or 'ca.' (e.g. '20',
'ca. 20', '>20').

(ii) In the second numeric field, enter a single value if preceded by
'<' or '<='.

(iii) Use both numeric fields and, as required, the lower and upper
qualifier field to enter a range of numeric values (e.g. '2 - 8' or '>2
<8').

pH value measured: Lower qualifier field providing a list with following
operators: >, >=, and ca.

pH value measured: Upper qualifier field providing a list with following
operators: <, <=, and ca.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:WATERSOL>

<i5:set>

<i5:PRECISION_PH_LOQUALIFIER>

<i5:PH_UPQUALIFIER>

SE04.08.00.0580

pH value

[no
label]

NUM

NUMBER/6/#0.##

g149

1

1

[N/A]

pH value measured: Upper numeric field for entering a numeric value only
if either a lower value is already entered to specify a numeric range or if
the numeric value is preceded by either operator '<' or '<='.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:WATERSOL>

<i5:set>

<i5:PRECISION_PH_LOQUALIFIER>

<i5:PH_UPVALUE>

SE04.08.00.0581

Remarks

[Remarks]

TEXT

STRING/255

g149

1

1

[N/A]

Enter any remarks related to the recorded value as appropriate.

Heading of field block 'Water solubility'

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:WATERSOL>

<i5:set>

<i5:REM>

<i5:REM>

SE04.08.00.0590

Details on results

[Details
on results]

TEXTAREA

STRING/32768

[N/A]

1

2

[N/A]

REMARKS:

Available predefined table(s) are displayed below, after this template.
See also List of Predefined Tables in Annex 2.

Give any further relevant information. As appropriate include table(s)
with raw data in the rich text field 'Any other information on results incl.
tables'. Upload predefined table(s) if any or adapt table(s) from study
report. Use table numbers in the sequence in which you refer to them in the
text (e.g. '... see Table 1').

Details on results.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:RESULTS_DETAILS>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE04.08.00.0600

Any other information on results incl. tables

[Any
other information on results incl. tables]

RICHTEXT

STRING/256000

[N/A]

1

1

[N/A]

In this field, you can enter any other remarks on results. You can also
open a rich text editor and create formatted text and tables or insert and
edit any excerpt from a word processing or spreadsheet document, provided it
was converted to the HTML format.

Note: Both the 'Materials and methods' section and 'Results' section. In
addition the fields 'Overall remarks' and 'Executive summary' allow rich text
entry.

Rich text editor field for creating formatted text and tables or inserting
and editing any excerpt from a word processing or spreadsheet document,
provided it was converted to the HTML format.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:REM_RS>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE04.08.00.0605

OVERALL REMARKS, ATTACHMENTS

[Overall
remarks, attachments]

HEAD-1

Heading level 1

[N/A]

1

1

[N/A]

Main heading under which 'Overall remarks, attachments' fields are
subsumed.

SE04.08.00.0610

Remarks on results including tables and figures

[Remarks
on results including tables and figures]

RICHTEXT

STRING/256000

[N/A]

1

1

[N/A]

In this field, you can enter any overall remarks or transfer free text
from other databases. You can also open a rich text editor and create
formatted text and tables or insert and edit any excerpt from a word
processing or spreadsheet document, provided it was converted to the HTML
format.

Note: One rich text editor field each is provided for the MATERIALS AND
METHODS and RESULTS section. In addition the fields 'Overall remarks' and
'Executive summary' allow rich text entry.

Rich text editor field for creating formatted text and tables or inserting
and editing any excerpt from a word processing or spreadsheet document,
provided it was converted to the HTML format.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:REM_ANYOTHER>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE04.08.00.0619

Attached background material

[Attached
background material]

HEAD BLOCK

Block label

g150

10

1

[N/A]

Attach any background document that cannot be inserted in any rich text
editor field, particularly image files (e.g. an image of a structural
formula).

Copy this block of fields for attaching more than one file.

Heading of field block 'Attached document'.

SE04.08.00.0620

Attached document

[Attached
document]

ATTACHMENT

STRING/32768

g150

1

1

[N/A]

Upload file by clicking the upload icon. As appropriate, enter any
additional information, e.g. language. The file name is displayed after
uploading the document.

File name of document uploaded, i.e. attached. No restriction as to file
type.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:AD>

<i5:set>

<i5:DOC>

<i5:DOC>

SE04.08.00.0630

Remarks

[Remarks]

TEXT

STRING/255

g150

1

1

[N/A]

As appropriate, include remarks, e.g. a short description of the content of
the attached document if the file name is not self-explanatory.

Remarks on attached document.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:AD>

<i5:set>

<i5:REM>

<i5:REM>

SE04.08.00.0639

Attached full study report

[Attached
full study report]

HEAD BLOCK

Block label

g151

10

1

[N/A]

If required, an electronic copy of the full study report can be attached
as WORD, pdf or other document type, which will not
be integrated in any report, but must be handled as separate files.

Note: In the export administration you can indicate whether the attached
files should be included in the data export or not.

Attached full study report

SE04.08.00.0640

Attached full study report

[Attached
full study report]

ATTACHMENT

STRING/32768

g151

1

1

[N/A]

Upload file by clicking the upload icon. As appropriate, enter any
additional information, e.g. language. The file name is displayed after
uploading the document.

Attached full study report

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:AD_STUDYREPORT>

<i5:set>

<i5:ATTACHMENT_BELOW>

<i5:ATTACHMENT_BELOW>

SE04.08.00.0642

Illustration (picture/graph)

[Illustration
(picture/graph)]

PICTURE

STRING/32768

[N/A]

1

1

[N/A]

Upload file by clicking the upload icon. As appropriate, enter any
additional information, e.g. language. The file name is displayed after
uploading the document.

Illustration (picture/graph)

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:PG_ILLUSTRATION>

<i5:set>

<i5:PIC_BELOW>

<i5:PIC_BELOW>

SE04.08.00.0645

APPLICANT'S SUMMARY AND CONCLUSION

[Applicant's
summary and conclusion]

HEAD-1

Heading level 1

[N/A]

1

1

[N/A]

Main heading under which generic 'Applicant's summary and conclusion'
fields are subsumed.

Provide the qualitative statement with regard to the water solubility according
to the author's conclusion. In the supplementary remarks field, indicate if
the author's conclusion was changed.

Interpretation of results.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:INTERPRETATION_RESULTS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE04.08.00.0651

Interpretation of results

[no
label]

SUP-TEXT

STRING/255

[N/A]

1

1

[N/A]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:INTERPRETATION_RESULTS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE04.08.00.0660

Conclusions

[Conclusions]

TEXTAREA

STRING/32768

[N/A]

1

1

[N/A]

Enter any conclusions if applicable.

Any conclusions either as adapted from the study report / publication or
indicated by the submitter.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:APPL_CL>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE04.08.00.0670

Executive summary

[Executive
summary]

RICHTEXT

STRING/256000

[N/A]

1

1

[N/A]

If required by the respective national/regional programme, briefly summarise the relevant aspects of the study including the
conclusions reached. If a specific format is prescribed, upload the
respective freetext template if available from the drop-down
list or copy it from the corresponding document.

Executive summary in which the relevant aspects of the study including the
conclusions reached are briefly summarised.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:PC_WATER_SOL>

<i5:APPL_EXEC_SUM>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE04.08.00.0680

Cross-reference to other study

[Cross-reference
to other study]

TEXTAREA

STRING/2000

[N/A]

1

1

[N/A]

A Cross-reference to other study or other studies can be included which
are considered relevant in the interpretation of the test results, e.g. for
supporting the conclusion that an effect observed was not substance-related.
Indicate the respective chapter(s) and record ID(s) and enter relevant
explanatory text.

Such cross-references may be useful if it is considered relevant to
discuss other results at the summary level of a single study. It should be
noted that the overall appraisal of results from different studies is
normally done in the hazard or risk assessment.

Note that any such cross-reference may become useless if a record is
either printed or exchanged on its own.

A cross-reference to another study or other studies including explanatory
text on why other results are relevant in the interpretation of the results
of a given study, e.g. for supporting any conclusions.